At a glance
ClinicalIndex Comparison Record- ✓Confirmation of Biomarker eligibility
- ✓ECOG performance status 0 or 1
- ✓Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC not eligible for curative surgery and/or definitive chemoradiotherapy
- ✓No prior systemic treatment for advanced unresectable or metastatic NSCLC
- ✕Known concomitant second oncogenic driver with available targeted treatment
- ✕Squamous cell histology NSCLC
- ✕Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C)
- ✕Prior treatment with a KRAS G12C inhibitor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
In the news
1 article- Samsung Bioepis宣布其Keytruda (Pembrolizumab)候选生物类似药SB27的积极1期和3期初步研究数据Business Wire Pharma·2026-06-29press release
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A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
In Brief
A Phase 1 clinical trial evaluating Divarasib, Pembrolizumab, and 3 other interventions for Non-Small Cell Lung Cancer. Currently recruiting, targeting 320 participants across 71 sites in 18 countries.
Signals
Detailed Summary
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
Study Details
Timeline
Arms & Interventions
Participants will be enrolled in different cohorts to receive divarasib (different dose levels will be evaluated) once a day (QD) combined with pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W). During the expansion stage, some participants are planned to be randomized to one divarasib combination dose level; other participants are planned to be randomized to another divarasib combination dose level. Divarasib will be given in combination with pembrolizumab.
Participants enrolled in this cohort will receive divarasib (different dose levels will be evaluated) QD combined with pembrolizumab 200 mg IV Q3W plus investigator's choice of platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed.
Participants enrolled in this cohort will receive one dose level of divarasib QD.
Participants enrolled in this cohort will receive one dose level of divarasib QD.
Interventions
Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle.
Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle.
Participants will receive IV carboplatin Q3W for four 21-day cycles.
Participants will receive IV cisplatin Q3W for four 21-day cycles.
Participants will receive IV pemetrexed Q3W.